A Phase 3 interventional study of montelukast sodium and placebo in Asthma, sponsored by Catholic University of the Sacred Heart. Completed at 1 site in Italy. Open to participants aged 6 Years to 14 Years. Per ClinicalTrials.gov, last updated 2008-05-09.
Sponsored by Catholic University of the Sacred Heart · Phase 3, Interventional, and Treatment
Leukotriene receptor antagonists (LTRAs) reduce fractional exhaled nitric oxide (FENO) concentrations in children with asthma, but the effect of LTRA withdrawal on FENO and lung function is unknown. We will aim to study the effect of treatment and withdrawal of montelukast, a LTRA, on airway inflammation as reflected by FENO and lung function in children with asthma.
A double-blind, randomized, placebo controlled, parallel group study will be undertaken in 18 atopic children with mild persistent asthma who will be treated with oral montelukast (5 mg/day for 4 weeks) and 18 atopic children with mild persistent asthma who will receive matching placebo.
A follow-up visit will be performed 2 weeks after montelukast or placebo withdrawal.
4,012 studies on the registry are indexed under Asthma; 514 are open to participants now.
This study's enrollment of 26 is below the median of 83 across 2,814 interventional studies indexed under Asthma.
Browse Asthma studies →Catholic University of the Sacred Heart is the lead sponsor of 237 studies on the registry; 29 are open to participants now.
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Exclusion Criteria:
Drug: montelukast sodium
Drug: placebo
one tablet 5 mg once/day for 4 weeks
one tablet 5 mg once/day for 4 weeks
post-treatment fractional exhaled nitric oxide
fractional exhaled nitric oxide 2 weeks after montelukast withdrawal
post-treatment FEV1
post-treatment FVC
post-treatment FEV1/FVC
post-treatment FEF25%-75%
FEV1 2 weeks after montelukast withdrawal
FVC 2 weeks after montelukast withdrawal
FEV1/FVC 2 weeks after montelukast withdrawal
FEF25%-75% 2 weeks after montelukast withdrawal
asthma exacerbation rate
This study is completed, as verified in May 2008. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Montelukast
Catholic University of the Sacred Heart →